Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Dietary Intervention

• Registration Number: NCT03997409
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. Although case series and prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for adults with T1DM, data in the pediatric T1DM population is limited. The investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (QOL) in pediatric T1DM patients on a LCD.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-25
• Study Start: 2019-11-18
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-06
• Results First Submitted: 2022-06-23
• Results First Submitted QC: 2022-06-23
• Last Update Submitted: 2022-06-23
• Results First Posted: 2023-05-08
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Diagnosed with T1DM for at least 12 months
• Age 13 to 21 years
• Total daily dose of insulin 0.5 to 1.25 units/kg/day
• Current use of an insulin pump and CGM
• HbA1c between 7% and 10%
• Tanner stage 3 to 5 on physical exam
• Participant or parent of participant use of smart phone
• Able to read and speak English

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Exclusion Criteria

• Any episode of diabetic ketoacidosis (DKA) in the last 12 months
• Any episode of severe hypoglycemia (defined as requiring assistance from another person, including coma, seizures, or episodes requiring glucagon, IV dextrose or oral carbohydrate administered by another person) in the last 12 months
• Any prior abnormal fasting lipid panel (LDL > 130)
• Additional dietary restrictions
• Following a weight-loss or otherwise restrictive diet
• Use of medication or supplements other than insulin to control blood glucose
• Use of medication or other supplements to lower lipids
• Pregnancy or breast feeding
• History of hemoglobinopathy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Carbohydrate Diet	Dietary Intervention	The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the LCD intervention will consume 25-35% of total daily intake from carbohydrates, 45-65% from fat and 10-30% from protein.
Standard Carbohydrate Diet	Dietary Intervention	The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the SCD intervention will consume 45-65% of total daily caloric intake from carbohydrates, 25-35% from fat and 10-30% from protein.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Baseline to week 12	HbA1c (%) change will be measured from baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percent of Time Spent Below the Glycemic Target of 70 mg/dL	Baseline to Week 12	Percent of time is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Change in Average Blood Glucose	Baseline to 12 weeks	Change in average blood glucose is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Percent of Time Spent Above the Glycemic Target of 140 mg/dL	Baseline to Week 12	Percent of time is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Percent of Time Spent in Hypoglycemia Below 50 mg/dL	Baseline to Week 12	Percent of time is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL	Baseline to Week 12	Percent of time is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Change in the Blood Glucose Standard Deviation	Baseline to 12 weeks	Change in the blood glucose standard deviation is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Change in Average Total Daily Dose of Insulin	Baseline to 12 weeks	Average Total Daily Dose of Insulin is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Change in Average Bolus Amount of Insulin Per Day	Baseline to 12 weeks	Average bolus amount of Insulin per day is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Change in Average Basal Amount of Insulin Per Day	Baseline to 12 weeks	Average Basal Amount of Insulin Per Day is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Change in Low Density Lipoprotein Particle Number	Baseline to 12 weeks	The number of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Change in High Density Lipoprotein Particle Number	Baseline to 12 weeks	The number of High Density Lipoprotein Particles (HDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Change in Small Low Density Lipoprotein Particle Number	Baseline to 12 weeks	The number of Small Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Change in Low Density Lipoprotein Size	Baseline to 12 weeks	The size of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Change in Concentration of Serum Ketones (Beta-hydroxybutyrate)	Baseline to 12 weeks	Change is measured by difference in concentration of serum ketones (beta-hydroxybutyrate)
Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module	Baseline to week 12	The PedsQL 3.0 Teen Report (ages 13-18) is composed of 28 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). The total possible range of scores 0-112 Higher scores indicate higher quality of life.
Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report	Baseline to week 12	Diabetes burden was measured using the Problem Areas in Diabetes (PAID-T) parent-report, a measure of how bothersome day-to-day problems are for adolescents with type 1 diabetes. The he PAID-T is a 26 item measure scored on a likert scale from one-to-six with a total possible scale score ranging from 26-156. A lower score represents less burden.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States